Assessment of the Axone Micro Quadripolar Lead for Enhanced Cardiac Resynchronization Therapy (ASTRAL-4LV)

MicroPort

Status

Active, not recruiting

Conditions

Cardiac Resynchronization Therapy

Heart Failure

Treatments

Device: Implantation of the Axone 4LV Lead

Study type

Interventional

Funder types

Industry

Identifiers

NCT04463641

LAXI01

Details and patient eligibility

About

The primary objective of this study is to assess the chronic safety and performance of the Axone left ventricular (LV) micro-lead.

Full description

This is a interventional, pivotal, prospective, single arm, open label, multicenter, international trial.

The device under investigation is the Axone system, consisting of:

Axone 4LV: an ultrathin, lumenless, quadripolar, IS4-compatible lead designed for left ventricular pacing for cardiac resynchronization therapy (CRT).
Axone µGuide: a dedicated, permanently implantable micro catheter designed for implantation of the Axone 4LV lead.

The primary endpoint data will be used to support CE marking of the Axone system.

The primary endpoints will be evaluated at 6 months post-implantation. Subjects will be followed-up at 6 weeks, 3 months, 6 months, 12 months post-implantation, then yearly until 4 years post-implantation.

Enrollment

92 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Indication for cardiac resynchronization therapy-defibrillator (CRT-D) device implant according to the latest ESC (European Society of Cardiology) guidelines
De-novo implant of a Platinium 4LV CRT-D device (or any newer 4LV CRT-D model manufactured by MicroPort CRM)
Reviewed, signed and dated informed consent form

Exclusion criteria

LV lead previous implant attempt
Upgrade to CRT from a previously implanted pacemaker or implantable cardioverter-defibrillator (ICD), or CRT device replacement
Known allergy to contrast media used for imaging during cardiac catheterization
Tricuspid valvular disease or any type of tricuspid replacement heart valve (mechanical or tissue)
Severe renal failure (creatinine clearance according to the Modification of Diet in Renal Disease (MDRD) formula < 30ml/min/m²)
Active myocarditis
Stroke, myocardial infarction or cardiac revascularization within 40 days prior to implant
Previous heart transplant or currently on heart transplant list
Life expectancy less than 1 year
Already included in another clinical study that could confound the results of this study
Pre-menopausal women / women in childbearing age, including pregnant and breastfeeding women
Less than 18 years old or under guardianship
Incapacitated subject, inability to understand the purpose of the study, or to meet follow-up visits at the implanting site as defined in the protocol
Diagnosis of drug addiction (substance use disorder)